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Biomarkers Correlation With Volemia

Predictive Value of Biomarkers on Volemia, Extra and Intra Vascular Varation and Hydroelectrolytic Disorders in Different ICU Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01858675
Acronym
ENVOL
Enrollment
66
Registered
2013-05-21
Start date
2012-03-31
Completion date
2014-12-31
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure, Renal Insufficiency

Keywords

ProADM, ProANP, proendothelin, proAVP, Cr 51, Volemia, fluid management, ICU patients, poly trauma patients

Brief summary

The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7 of ICU admission are correlated with Intravascular volume assessed by Cr 51 on red blood cells (Day 2 and Day 7) and by I 125 on albumine Day 7. The correlation of these Biomarkers are also evaluted with other markers such as erythropoietin and catecholamines. 80 ICU patients are included.

Interventions

OTHERBiomarkers, red blood cells and plasma assessment

Sponsors

ThermoFisher Scientific Brahms Biomarkers France
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 20 Cerebral Hemorrhage * 20 Head Injury * 20 post surgery non traumatic non neuro * 20 Polytrauma patients

Exclusion criteria

* Heart failure NYHA III or IV * Renal insufficiency creatinin clearance \< 30 ml/mn * age \< 18 Y * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Predictive value of biomarkers changes in Volemia variationat Day 2, Day 5 and Day 7 of ICU admissionCorrelation with total blood volume(assessed by Cr 51) and biomarkers(Mr proADM, Mr proANP, CT proAVP and proendothelin)changes

Secondary

MeasureTime frameDescription
Predictive value of biomarkers changes with efficient volemia, fluid managements and other Markers such erythropoietinat Day 2, Day 5 and Day 7 of ICU admissionCorrelation with efficient volemia and Biomarkers ( Mr proADM, Mr proANP, CT proAVP and proendothelin)changes.
Predictive value of Biomarkers with APACHE II and SOFA score and Prognosis at ICU dischargeat Day 2 , Day 5 and Day 7 of ICU admission and at dischargeCorrelation of Biomarkers changes with APACHE II and SOFA score and Mortality at Day 2, Day 5 and Day 7 of their ICU admission and at ICU discharge.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026